FDA recalls brain biopsy needles due to stainless steel debris
The U.S. Food and Drug Administration (FDA) has issued a recall on behalf of Elekra for its disposable biopsy needle kits, specifically those used with the Leksell Stereotactic System for the purpose of brain tissue biopsies. Due to a risk of serious injury or death to patients, this recall has been given the most serious designation.
Due to a manufacturing defect, the internal cavity of the biopsy needles may contain microscopic stainless steel debris that could enter brain tissue and paralyze or kill a patient. There have been no reported injuries; however, use of Ekekra needles must cease immediately.
What is being recalled?
The lot number for the needles that are known to be at risk of containing the metal debris is 873874875R. However, multiple packages of Elekta disposable biopsy needle kits are subject to the recall.
Below are the affected products, along with their associated unique device identifier (UDI):
- Package including 6 needles: (01)0 7340048 30034 6 (17) 260401 (10) 873874875R (240) 911933
- Package including 1 needle: (01)0 7340048 30800 7 (17) 260301 (10) 873874875R (240) 911761
- Inner sterile bag, including 1 needle: (01)0 7340048 30801 4 (17) 260301 (10) 873874875R (240) 912465
Next Steps
If you have a needle kit from an affected lot, do not use it. Dispose of the entire kit immediately. Clinicians are advised to contact their Elektra representative to acquire new needles.
All known customers were notified by the company in September. However, the FDA and Elektra ask that this recall notice be shared to ensure all recalled products are removed from clinical settings.
The notice can be found here.
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